Table 2 Response rates in the mITT population
Response Data are n (%) unless stated otherwise | Belumosudil 200 mg once daily (N = 30) |
|---|---|
ORR | 22 (73.3%) |
95% CI | 54.1–87.7% |
PR | 22 (73.3%) |
ORR for responses occurring within 6 months of treatment | 20 (66.7%) |
95% CI | 47.2–82.7% |
PR | 20 (66.7%) |
Median DOR, weeks (95% CI) | NR (20.3–NR) |
Median TTR, weeks (range) | 4.3 (3.9–48.1) |
Improvement from baseline based on LSSa | |
Overall | 15 (50.0%) |
Responder, n/N (%) | 12/22 (54.5%) |
Non-responder, n/N (%) | 3/8 (37.5%) |
Median duration of improvement, weeks (range) | 16 (4–69) |
≥ 16 weeks | 9 (30.0%) |
≥ 24 weeks | 5 (16.7%) |
≥ 32 weeks | 5 (16.7%) |
Improvement from baseline based on LSS on two consecutive visitsa | |
Overall | 10 (33.3%) |
Responder, n/N (%) | 9/22 (40.9%) |
Non-responder, n/N (%) | 1/8 (12.5%) |
FFS, % (95% CI) | |
Median, months | NR (7.8–NR) |
6 months | 73 (54–86%) |
12 months | 56 (37–72%) |
TTNT, % (95% CI) | |
Median, months | NR (8.9–NR) |
6 months | 77 (57–88%) |
12 months | 63 (43–77%) |
OS, % (95% CI) | |
Median, months | NR (NR–NR) |
6 months | 97 (79–100%) |
12 months | 87 (68–95%) |